AnxietyPhase 2NCT00979693
Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma
A Phase 2 study testing psilocybin in people with Anxiety and Stage IV Melanoma, run by Multidisciplinary Association for Psychedelic Studies at 1 site in United States.
Trial summary
This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Stage IV Melanoma
- What is being tested?
- psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with Stage IV melanoma with a life expectancy of one year or less
- Meet diagnostic criteria for anxiety on the SCID, or a score of 8 or higher on the HADS Anxiety score.
- Diagnosis must be a new diagnosis of anxiety subsequent to diagnosis with melanoma.
- Are 18 years or older
- Live with another adult who is their primary caregiver, who can also provide transportation to and from the cancer center for each experimental session and who also consents to take part in a parallel investigation of anxiety and depression in primary caregivers. The same caregiver may remain overnight with participants after each psilocybin session.
- Have a Mini-Mental State Exam score of 27 or higher, an indication of mental functioning.
Show all 10Show fewer
- Are willing to commit to medication dosing, experimental sessions with overnight stay, traveling to follow-up sessions, and to complete the evaluation
- Are willing to refrain from taking any anti-depressants during the study period.
- Are willing to refrain from taking any benzodiazepines during the 24 hours preceding each scheduled psilocybin, placebo, or open label session.
- Are able to communicate in English.
Who cannot join
- Meet DSM-IV criteria for bipolar disorder, schizophrenia, or other psychotic disorders.
- Meet DSM-IV criteria for abuse of or dependence on any substance (other than caffeine or nicotine) in the past 60 days.
- Have first-degree relatives (as parent or full sibling) with past or present psychiatric disorders, including schizophrenia, bipolar affective disorder and other psychoses, but excluding mood disorders.
- Cannot have a current diagnosis of anxiety disorder that predates diagnosis with melanoma.
- Have used psilocybin or psilocybin-containing mushrooms within the past year.
- Require concomitant treatment with anti-psychotic medications, prescribed for the management of either psychiatric symptoms or nausea. The restriction on 5HT2C/5HT3 antagonists is applicable for 24 hours before and including the day of the study.
Show all 13Show fewer
- Are cachectic [exhibiting signs of wasting] as indicated by loss of 10% or greater of their total weight.
- Have been diagnosed with primary or metastatic cancer of the CNS confirmed by MRI, within 6 weeks of participation in the study.
- Have uncontrolled hypertension.
- Have baseline laboratory values indicative of severely compromised hepatic function, indicated by unacceptable levels of alkaline phosphatase (ALP) above 750 U/L. Participants must also have laboratory blood screening indicating ALP below 750 U/L immediately prior to administration of psilocybin.
- Are women who are pregnant or nursing, or of child bearing potential and are not practicing an effective means of birth control.
- Are reasonably judged to present a serious suicide or homicide risk or who are likely to require psychiatric hospitalization during the course of the study.
- Are unable to fully understand the potential risks and benefits of the study and give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
About this study
Official title: Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.
This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study will measure anxiety, depression, quality of life and spirituality before and after psilocybin-assisted psychotherapy, natural killer cells (a type of immune cell) will be counted from blood samples taken the day after psilocybin-assisted psychotherapy, and people will keep daily diaries reporting on how anxious they feel for each day in the study.
Read the detailed description
Melanoma is a cancer arising from pigment-producing cells, or melanocytes. These cells are chiefly located in the skin, but they can also be found in other parts of the body, including eyes, ears and GI tract. A diagnosis of stage IV melanoma can create great stress and anxiety for an individual and his or her caregivers. Psilocybin (4-phosphoryloxy- N,N-dimethyl-tryptamine) is a psychedelic (hallucinogenic) compound found in certain species of mushrooms that can produce spiritual or mystical experiences and that has been used in psychotherapy prior to being made illegal. This study will be a randomized, active-placebo controlled pilot study of the safety and efficacy of psilocybin-assisted psychotherapy as a means of managing anxiety in association with stage IV melanoma. This study will examine whether two sessions of psilocybin-assisted psychotherapy scheduled seen to 14 days apart will reduce anxiety, improve quality of life and be safe in people with stage IV melanoma.
Subjects in this study will have a 66% chance of receiving the full dose of 25 mg psilocybin and a 33% of receiving 4 mg psilocybin. The first dose is expected to change how people feel, think and see the world, while the lower dose is expected to have only slight effects. Each subject will receive these conditions at random, as if by coin-toss. The researchers, including the therapists, and the subject will not know whether they are assigned to get 25 or 4 mg psilocybin.
The entire study can last up to three and a half months (14 weeks) but the main part of the study lasts six weeks. After the researchers determine that a person with stage IV melanoma and anxiety can be in the study, there will be two introductory psychotherapy sessions with the therapist-investigators. They will prepare the participant for psilocybin-assisted psychotherapy. The subject will have a day-long psilocybin-assisted psychotherapy session after introductory sessions, and he or she will remain overnight at the clinic. There will be a psychotherapy follow-up scheduled the day after each psilocybin-assisted session to help people work with the psilocybin-assisted psychotherapy, and there will be a psychotherapy session in between the first and second psilocybin-assisted psychotherapy sessions. Two weeks after the second psilocybin-assisted psychotherapy session, subjects will return for another follow-up visit. The subjects will answer questions or fill out questionnaires about anxiety, depression, quality of life, spirituality and sense of self at the start of the study, two weeks after the second psilocybin-assisted session and at least once during the study. Subjects will have blood draws to assess liver function before each psilocybin-assisted session and they will have a blood draw to assess natural killer (NK) cells the day after each psilocybin-assisted session. On the day after each psilocybin-assisted session, subjects will also complete a questionnaire about their experiences during the psilocybin-assisted session.
Two weeks after the second experimental psilocybin-assisted session, subjects will learn if they got the full or active placebo dose of psilocybin. Any of the three subjects who receive the active placebo dose can take part in an "open-label" study phase that will last another six weeks. The open-label phase will be nearly identical to those used in the first study phase except that there will be one, and not two, introductory psychotherapy sessions, and the subject and therapists will know that the subject will be receiving 25 mg psilocybin. People who got the full dose of 25 mg psilocybin will not take part in the open-label study phase.
If they are well enough to do so, subjects who received the full dose of psilocybin will have anxiety, depression, quality of life and spirituality measured again two months after the second experimental session. Subjects who received active placebo psilocybin will have anxiety, depression, quality of life and spirituality measured two months after the second open-label psilocybin-assisted session.
- Conditions
- Anxiety, Stage IV Melanoma
- Being tested
- psilocybin
- Keywords
- anxiety, stage IV melanoma, depression, spirituality, pain
- Medical subject headings
- Anxiety Disorders, Melanoma, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psilocybinDrug
25 mg psilocybin administered orally once during each of the two day-long psychotherapy sessions.
psilocybinDrug
4 mg psilocybin orally administered once during each of two day-long psychotherapy session
| Study group | Role | What they receive |
|---|---|---|
| Full Dose | Experimental | Participant will receive 25 mg psilocybin during two day-long sessions of psychotherapy in combination with psilocybin, with each session scheduled seven to 14 days apart. Receives: Drug: psilocybin |
| Active Placebo | Active comparator | The participant will receive 4 mg psilocybin during two day-long sessions of psychotherapy in combination with psilocybin, with sessions scheduled seven to 14 days apart. Receives: Drug: psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
Measured: Baseline, 1st non-drug intro psychotherapy, day of psilocybin-assited psychotherapy, non-drug psychotherapy between experimental sessions, day of psilocybin-assisted session 2, two weeks after second psilocybin-assisted session
Secondary outcomes (6)
Spielberger-State-Trait Inventory (STAI)
Measured: Baseline, 1st intro psychotherapy, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks after experimental session 2
Hamilton Anxiety Rating Scale
Measured: Baseline, non-drug psychotherapy between sessions, two weeks after second experimental session
Natural killer (NK) cell count
Measured: Day after experimental session 1, day after experimental session 2
European Organization For Research and Treatment of Cancer; Quality of Life Questionnaire-C15
Measured: Baseline, 1st intro psychotherapy, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks post second experimental session
Hamilton Depression Rating Scale
Measured: Baseline, non-drug psychotherapy in between experimental sessions, two weeks after second experimental session
Functional Assessment of Chronic Illness Therapy-spirituality
Measured: Baseline, first intro psychotherapy sesison, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks after second experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startJan 2012
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: The study was suspended because the PI was unable to get permission from his department to submit the protocol to the local IRB?"
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multidisciplinary Association for Psychedelic Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameet Kumar, Ph.D, Principal investigator, Psycho-oncologist, Mount Sinai Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979693
- Sponsor's protocol ID
- PCA1
- Status last verified
- Dec 2023
- First submitted
- 16 Sep 2009
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.
- ClinicalTrials.gov ID
- NCT00979693
- Acronym / sponsor ID
- PCA1
- Conditions
- Anxiety, Stage IV Melanoma
- Keywords
- anxiety, stage IV melanoma, depression, spirituality, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was suspended because the PI was unable to get permission from his department to submit the protocol to the local IRB?"
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Multidisciplinary Association for Psychedelic StudiesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study will measure anxiety, depression, quality of life and spirituality before and after psilocybin-assisted psychotherapy, natural killer cells (a type of immune cell) will be counted from blood samples taken the day after psilocybin-assisted psychotherapy, and people will keep daily diaries reporting on how anxious they feel for each day in the study.
Detailed description
Melanoma is a cancer arising from pigment-producing cells, or melanocytes. These cells are chiefly located in the skin, but they can also be found in other parts of the body, including eyes, ears and GI tract. A diagnosis of stage IV melanoma can create great stress and anxiety for an individual and his or her caregivers. Psilocybin (4-phosphoryloxy- N,N-dimethyl-tryptamine) is a psychedelic (hallucinogenic) compound found in certain species of mushrooms that can produce spiritual or mystical experiences and that has been used in psychotherapy prior to being made illegal. This study will be a randomized, active-placebo controlled pilot study of the safety and efficacy of psilocybin-assisted psychotherapy as a means of managing anxiety in association with stage IV melanoma. This study will examine whether two sessions of psilocybin-assisted psychotherapy scheduled seen to 14 days apart will reduce anxiety, improve quality of life and be safe in people with stage IV melanoma.
Subjects in this study will have a 66% chance of receiving the full dose of 25 mg psilocybin and a 33% of receiving 4 mg psilocybin. The first dose is expected to change how people feel, think and see the world, while the lower dose is expected to have only slight effects. Each subject will receive these conditions at random, as if by coin-toss. The researchers, including the therapists, and the subject will not know whether they are assigned to get 25 or 4 mg psilocybin.
The entire study can last up to three and a half months (14 weeks) but the main part of the study lasts six weeks. After the researchers determine that a person with stage IV melanoma and anxiety can be in the study, there will be two introductory psychotherapy sessions with the therapist-investigators. They will prepare the participant for psilocybin-assisted psychotherapy. The subject will have a day-long psilocybin-assisted psychotherapy session after introductory sessions, and he or she will remain overnight at the clinic. There will be a psychotherapy follow-up scheduled the day after each psilocybin-assisted session to help people work with the psilocybin-assisted psychotherapy, and there will be a psychotherapy session in between the first and second psilocybin-assisted psychotherapy sessions. Two weeks after the second psilocybin-assisted psychotherapy session, subjects will return for another follow-up visit. The subjects will answer questions or fill out questionnaires about anxiety, depression, quality of life, spirituality and sense of self at the start of the study, two weeks after the second psilocybin-assisted session and at least once during the study. Subjects will have blood draws to assess liver function before each psilocybin-assisted session and they will have a blood draw to assess natural killer (NK) cells the day after each psilocybin-assisted session. On the day after each psilocybin-assisted session, subjects will also complete a questionnaire about their experiences during the psilocybin-assisted session.
Two weeks after the second experimental psilocybin-assisted session, subjects will learn if they got the full or active placebo dose of psilocybin. Any of the three subjects who receive the active placebo dose can take part in an "open-label" study phase that will last another six weeks. The open-label phase will be nearly identical to those used in the first study phase except that there will be one, and not two, introductory psychotherapy sessions, and the subject and therapists will know that the subject will be receiving 25 mg psilocybin. People who got the full dose of 25 mg psilocybin will not take part in the open-label study phase.
If they are well enough to do so, subjects who received the full dose of psilocybin will have anxiety, depression, quality of life and spirituality measured again two months after the second experimental session. Subjects who received active placebo psilocybin will have anxiety, depression, quality of life and spirituality measured two months after the second open-label psilocybin-assisted session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Dose | Experimental | Drug: psilocybinParticipant will receive 25 mg psilocybin during two day-long sessions of psychotherapy in combination with psilocybin, with each session scheduled seven to 14 days apart. |
| Active Placebo | Active comparator | Drug: psilocybinThe participant will receive 4 mg psilocybin during two day-long sessions of psychotherapy in combination with psilocybin, with sessions scheduled seven to 14 days apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have been diagnosed with Stage IV melanoma with a life expectancy of one year or less
- Meet diagnostic criteria for anxiety on the SCID, or a score of 8 or higher on the HADS Anxiety score.
- Diagnosis must be a new diagnosis of anxiety subsequent to diagnosis with melanoma.
- Are 18 years or older
- Live with another adult who is their primary caregiver, who can also provide transportation to and from the cancer center for each experimental session and who also consents to take part in a parallel investigation of anxiety and depression in primary caregivers. The same caregiver may remain overnight with participants after each psilocybin session.
Key exclusion criteria (13 listed)
- Meet DSM-IV criteria for bipolar disorder, schizophrenia, or other psychotic disorders.
- Meet DSM-IV criteria for abuse of or dependence on any substance (other than caffeine or nicotine) in the past 60 days.
- Have first-degree relatives (as parent or full sibling) with past or present psychiatric disorders, including schizophrenia, bipolar affective disorder and other psychoses, but excluding mood disorders.
- Cannot have a current diagnosis of anxiety disorder that predates diagnosis with melanoma.
- Have used psilocybin or psilocybin-containing mushrooms within the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psilocybin25 mg psilocybin administered orally once during each of the two day-long psychotherapy sessions. | Drug | Full Dose |
| psilocybin4 mg psilocybin orally administered once during each of two day-long psychotherapy session | Drug | Active Placebo |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: Baseline, 1st non-drug intro psychotherapy, day of psilocybin-assited psychotherapy, non-drug psychotherapy between experimental sessions, day of psilocybin-assisted session 2, two weeks after second psilocybin-assisted session
6 secondary outcomes
Spielberger-State-Trait Inventory (STAI)
Time frame: Baseline, 1st intro psychotherapy, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks after experimental session 2
Hamilton Anxiety Rating Scale
Time frame: Baseline, non-drug psychotherapy between sessions, two weeks after second experimental session
Natural killer (NK) cell count
Time frame: Day after experimental session 1, day after experimental session 2
European Organization For Research and Treatment of Cancer; Quality of Life Questionnaire-C15
Time frame: Baseline, 1st intro psychotherapy, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks post second experimental session
Hamilton Depression Rating Scale
Time frame: Baseline, non-drug psychotherapy in between experimental sessions, two weeks after second experimental session
Functional Assessment of Chronic Illness Therapy-spirituality
Time frame: Baseline, first intro psychotherapy sesison, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks after second experimental session
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameet Kumar, Ph.D principal investigator
Psycho-oncologist, Mount Sinai Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing psilocybin in people with Anxiety and Stage IV Melanoma, run by Multidisciplinary Association for Psychedelic Studies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: Baseline, 1st non-drug intro psychotherapy, day of psilocybin-assited psychotherapy, non-drug psychotherapy between experimental sessions, day of psilocybin-assisted session 2, two weeks after second psilocybin-assisted session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.